CABG Outperforms PCI in Patients With Multivessel Disease: FRAME 3 Trial

A recent study suggests, for patients with three-vessel coronary artery disease, CABG has a better outcome than fractional flow reserve (FFR)-guided PCI. The study findings were published in the New England Journal of Medicine on 13 January 2022.

Fractional flow reserve (FFR) is a measure of the pressure gradient across a coronary lesion, is technically easy to assess, and trials have shown better outcomes when PCI is guided by FFR than when it is guided by angiography alone. Moreover, studies comparing CABG and FFR-guided PCI on patients with three-vessel coronary artery disease are lacking. Also, it has not been clear whether its use to guide PCI might make PCI a reasonable alternative to CABG for patients with multivessel coronary disease. Therefore, Dr William F. Fearon and his team conducted a trial to evaluate whether FFR-guided PCI and CABG have similar outcomes in patients with multivessel CAD.

The Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 trial was a multicenter, international, randomized, controlled non-inferiority trial. The researchers randomly assigned 1500 patients with angiographically defined three-vessel coronary artery disease to undergo CABG or FFR-guided PCI with current-generation zotarolimus-eluting stents. . The major outcome assessed was the occurrence within 1 year of a major adverse cardiac or cerebrovascular event, defined as death from any cause, myocardial infarction, stroke, or repeat revascularization. The prespecified non-inferiority margin was a hazard ratio of 1.65. They also assessed the composite of death, myocardial infarction, or stroke and safety endpoints.

Key findings of the study:

• At 1 year, they found that the incidence of the primary endpoint was 10.6% in the FFR-guided PCI group and 6.9% in the CABG group (hazard ratio, 1.5), findings that failed to demonstrate non-inferiority of PCI.
• They also found that the incidence of death, myocardial infarction, or stroke was 7.3% in the FFR-guided PCI group and 5.2% in the CABG group.
• However, they noted a higher incidence of major bleeding, arrhythmia, and acute kidney injury in the CABG group than in the FFR-guided PCI group.

The authors concluded, "In patients with three-vessel coronary artery disease, FFR-guided PCI was not found to be non-inferior to CABG with respect to the incidence of a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year. "

In an accompanying editorial Dr Frederick G.P. Welt wrote, "The FAME 3 trial bolsters the role of CABG as the benchmark for patients with multivessel coronary disease. However, a multidisciplinary approach and shared decision making remain fundamental to the management of multivessel coronary disease in our daily practices".

For further information:

DOI: 10.1056/NEJMoa2112299